Medical Safety Officer - Electrophysiology

Role Summary

The Medical Safety Officer (MSO) provides medical safety stewardship for Medical Device products, with a focus on Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing. The MSO collaborates across R&D, Quality, Regulatory, Clinical, Medical Affairs, Epidemiology and Safety to assess safety signals, implement safety programs, and influence product life-cycle decisions from development through launch and commercial life.

• Assess product risk-benefit and provide medical input on risk management documents, health hazard evaluations, clinical evaluation reports, safety surveillance plans, and safety-related materials; review advisories, labeling, and training content to minimize patient risk.
• Interpret post-marketing safety data, aggregate complaint data, adverse event reports, and literature references with potential safety data.
• Influence design and interpretation of safety studies and SSP activities; represent Medical Safety in product reviews during development.
• Evaluate medical impact of manufacturing and design issues; oversee and guide product safety performance.
• Monitor external sources and identify emerging issues across regulatory, market, literature, and publications.
• Advise on failure investigations and provide medical opinions on reportability; collect additional medical data from customers/users as needed.
• Provide safety communications to prevent repeated adverse events; discuss AE investigations with healthcare professionals upon request.
• Serve as medical representative in review processes for field actions; evaluate effectiveness of field safety corrective actions.
• Ensure consistency in medical evaluations, safety decisions, and overall product safety assessments.
• Deploy standard practices with MD CMO; use appropriate metrics to assess patient safety processes.
• Contribute to defining product harms/hazards and criteria for reportability; act as subject-matter expert in audits and regulatory interactions.
• Review and approve safety-related reports and filings; respond to regulatory bodies, clinicians, and patients as needed; coordinate with Regional Safety Officers for timely information sharing.

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent.
• Minimum of 3 years clinical or research experience.
• Relevant experience or training in the Cardiovascular field.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Knowledge of basic statistical techniques and epidemiological principles.
• Knowledge of pre-clinical or clinical research concepts.

• Specialties:
  Electrophysiology, Interventional Cardiology, Cardiology, Interventional Radiology.
• Experience in risk evaluation and mitigation; medical device/pharmaceutical industry experience.
• Clinical study/research experience; ability to work with senior leadership in a global company.
• Advanced statistical knowledge (e.g., multivariate analysis); knowledge of local and international Medical Device regulations.

• Clinical Operations;
  Compliance Management;
  Risk Management;
  Safety Investigations;
  Regulatory interactions;
  Data interpretation;
  Stakeholder collaboration;
  Problem solving;
  Medical risk assessment.